Myeloid LeukemiaPhase 2/3NCT00111345
Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents
A Phase 2/3 study testing Anthracyclines, liposomal daunorubicin and 2-CDA in people with Myeloid Leukemia, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Myeloid Leukemia
- What is being tested?
- Anthracyclines, liposomal daunorubicin and 2-CDA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2004to Mar 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age from >0 to </=18 years
- De novo AML, including children with Down syndrome, primary myelosarcomas or acute mixed lineage leukemia/biphenotypic leukemia (predominantly myeloid)
- Admission to one of the member hospitals in Germany participating in the study AML-BFM 2004
Who cannot join
- Children with pre-existing syndromes (except Down syndrome)
- AML as secondary malignancy
- Accompanying diseases which do not allow therapy according to the protocol
- Pre-treatment for more than 14 days with another intensive induction therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Children's Hospital Muenster, Department of Paediatric Haematology and Oncology
Münster, North Rhine-Westphalia, D-48129
About this study
Official title: Multicenter Therapy-Optimization Trial AML-BFM 2004 for the Treatment of Acute Myeloid Leukemias in Children and Adolescents
Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Against the background that about 40% of the patients still die from immediate causes of an underlying disease relapse or of nonresponse, it seems to be justifiable to intensify therapy - especially for high-risk patients - which on its parts will require an optimization of supportive measures. As the present risk stratification into standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the risk-adapted therapy strategy.
The aim of the study is to improve prognosis in children with AML by intensification of cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.
Read the detailed description
During the last decade, prognosis in acute myelogenous leukemia (AML) in childhood has improved considerably, but still 30% of the children experience a relapse of disease and further 10% fail to respond sufficiently to the present therapies. A further intensification of therapy might improve the overall survival of these children, but possible, implicit side effects have to be considered carefully. Increase in dose intensification of the proven, effective anthracyclines will be limited by the risk of cumulative cardiotoxicity. A liposomal formulation of daunorubicin may offer a possibility to increase dosage, at least partially, without causing cumulative cardiotoxicity. Objective one of this randomised study is to ascertain if this dose increase improves therapy response and overall survival at acceptable toxicity. The previous experiences with liposomal daunorubicin, gathered from the relapse studies AML-BFM Rez 97 and International Therapy Study Relapsed AML 2001/012 as well as from the pilot study AML-BFM 2002P, have shown that the induction therapy is feasible in clinical centers with experience in AML therapy without leading to a marked increase of toxicity or prolongation of granulocytopenia.
First results of study AML-BFM 98 have shown that the patients of the standard risk (SR) group did not benefit from an additional, second induction (HAM). On this account we did not reintroduce this second induction course in the present study AML-BFM 2004. However, SR patients will take part in the randomisation of initial therapy with a general view to achieving higher effectiveness.
For patients of the high-risk group, the administration of 2-chloro-2-deoxyadenosine (2-CDA) will be integrated in the first phase of consolidation to achieve an even higher intensification. It could be shown that 2-CDA possesses good antileukemic activity in pediatric and adult AML. In a phase-II study it could also be demonstrated that 2-CDA has good effectiveness in combination with cytarabine. Results of phase-II studies conducted at St. Jude Children's Hospital, Memphis, showed that 2-CDA has good effectiveness especially in children with monoblastic leukemias (FAB M4/M5). Consequently, this intensification for high-risk patients, who present in more than half of the cases with monoblastic leukemias (FAB M4/5), may allow further improvement of therapy for this cohort. The pilot study AML-BFM 2002P confirmed that the study design was practicable without increasing significantly the risk of higher toxicity. However, median duration of aplasia was significantly prolonged in comparison to that of the AI (cytarabine, idarubicin)-block. Objective two of this study is to determine by randomisation if an improvement of efficiency is possible.
Study AML-BFM 98 has already focussed on the question of whether or not doses of CNS irradiation of 12 Gy and 18 Gy are equivalent with regard to their capacity of reducing the risk of relapse. As the results of study AML-BFM 87 confirmed the necessity of CNS irradiation, but did not reveal the necessary minimum dose, this randomisation has been implemented in order to prevent, as far as possible, late sequelae of CNS irradiation by reducing the radiation dose (= objective three).
As the number of patients of study AML-BFM 98 was not sufficient to resolve this question, this randomised analysis has been extended for a second period and will therefore be continued in the current study AML-BFM-2004.
Besides the intensification of cytostatic therapy, study AML-BFM 2004 seeks to optimise the quality of supportive therapy by implementing measures of quality assurance. This demands an up-to-date, complete documentation of each therapy phase. In studies AML-BFM 93 and 98, about 12% of deaths were due to primary complications such as leukostasis syndrome, haemorrhage or severe infections (4%), infections in aplasia before achieving remission (4%) or infections in remission (4%). Maybe the lives of even more children will be saved in the future by improved standards for the prevention of primary complications. Further, the efficacy of chemotherapy could be improved by less delays in therapy which are often due to infections or other complications.
- Conditions
- Myeloid Leukemia
- Being tested
- Anthracyclines, liposomal daunorubicin, 2-CDA, AI
- Keywords
- Acute, myeloid, leukemia, Acute myeloid leukemia
- Medical subject headings
- Leukemia, Myeloid, Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthracyclinesDrug
Also called Idarubicin
3x12 mg/qm
liposomal daunorubicinDrug
Also called Daunoxome
3x80 mg/qm
2-CDADrug
Also called Cladribine
2x6 mg/qm
AIDrug
AI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Daunoxome, standard risk Receives: Drug: liposomal daunorubicin |
| 2 | Active comparator | Idarubicin, standard risk Receives: Drug: Anthracyclines |
| 3 | Experimental | Daunoxome, high-risk, 2-CDA Receives: Drug: 2-CDA |
| 4 | Active comparator | Idarubicin, high-risk, nothing Receives: Drug: AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free and absolute survival from the date of diagnosis concerning objective 1 and from the date of randomisation concerning objective 2
Measured: 5 years
Concerning objective 3: Disease-free survival from the date of randomisation
Measured: 5 years
Secondary outcomes (1)
Cardiotoxicity
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2005 (estimated)
- Study startMar 2004
- Primary completionMar 2012
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Responsible party
- Sponsor
- Investigators
- Ursula Creutzig, Prof. Dr. med., Principal investigator, Medical School HannoverDirk Reinhardt, Prof. Dr. med., Principal investigator, Medical School Hanover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111345
- Sponsor's protocol ID
- BfArM 4022064
- Other IDs
- DKH 50-2728
- Status last verified
- Mar 2012
- First submitted
- 19 May 2005
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Steidel E, Orhan E, Rasche M, Pigazzi M, Tregnago C, Hoffmeister LM, Walter C, Dworzak M, Muhlegger N, von Neuhoff N, Locatelli F, Reinhardt D, Schneider M. Prognostic Value of Molecular Genetic Measurable Residual Disease (MRD) Monitoring in Pediatric Acute Myeloid Leukemia Expressing KMT2A::MLLT10. Eur J Haematol. 2025 Nov;115(5):493-504. doi: 10.1111/ejh.70019. Epub 2025 Aug 13.
PubMed 40803346Tramsen L, Salzmann-Manrique E, Bochennek K, Klingebiel T, Reinhardt D, Creutzig U, Sung L, Lehrnbecher T. Lack of Effectiveness of Neutropenic Diet and Social Restrictions as Anti-Infective Measures in Children With Acute Myeloid Leukemia: An Analysis of the AML-BFM 2004 Trial. J Clin Oncol. 2016 Aug 10;34(23):2776-83. doi: 10.1200/JCO.2016.66.7881. Epub 2016 Jun 6.
PubMed 27269945Hassler A, Bochennek K, Gilfert J, Perner C, Schoning S, Creutzig U, Reinhardt D, Lehrnbecher T. Infectious Complications in Children With Acute Myeloid Leukemia and Down Syndrome: Analysis of the Prospective Multicenter Trial AML-BFM 2004. Pediatr Blood Cancer. 2016 Jun;63(6):1070-4. doi: 10.1002/pbc.25917. Epub 2016 Jan 27.
PubMed 26814618Creutzig U, Zimmermann M, Bourquin JP, Dworzak MN, Fleischhack G, Graf N, Klingebiel T, Kremens B, Lehrnbecher T, von Neuhoff C, Ritter J, Sander A, Schrauder A, von Stackelberg A, Stary J, Reinhardt D. Randomized trial comparing liposomal daunorubicin with idarubicin as induction for pediatric acute myeloid leukemia: results from Study AML-BFM 2004. Blood. 2013 Jul 4;122(1):37-43. doi: 10.1182/blood-2013-02-484097. Epub 2013 May 23.
PubMed 23704089Creutzig U, Zimmermann M, Bourquin JP, Dworzak MN, Fleischhack G, von Neuhoff C, Sander A, Schrauder A, von Stackelberg A, Ritter J, Stary J, Reinhardt D. CNS irradiation in pediatric acute myleoid leukemia: equal results by 12 or 18 Gy in studies AML-BFM98 and 2004. Pediatr Blood Cancer. 2011 Dec 1;57(6):986-92. doi: 10.1002/pbc.22955. Epub 2011 Apr 7.
PubMed 21480469Klusmann JH, Creutzig U, Zimmermann M, Dworzak M, Jorch N, Langebrake C, Pekrun A, Macakova-Reinhardt K, Reinhardt D. Treatment and prognostic impact of transient leukemia in neonates with Down syndrome. Blood. 2008 Mar 15;111(6):2991-8. doi: 10.1182/blood-2007-10-118810. Epub 2008 Jan 8.
PubMed 18182574Meyer LH, Queudeville M, Eckhoff SM, Creutzig U, Reinhardt D, Karawajew L, Ludwig WD, Stahnke K, Debatin KM. Intact apoptosis signaling in myeloid leukemia cells determines treatment outcome in childhood AML. Blood. 2008 Mar 1;111(5):2899-903. doi: 10.1182/blood-2007-08-109058. Epub 2007 Dec 14.
PubMed 18083847
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Therapy-Optimization Trial AML-BFM 2004 for the Treatment of Acute Myeloid Leukemias in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00111345
- Acronym / sponsor ID
- BfArM 4022064
- Conditions
- Myeloid Leukemia
- Keywords
- Acute, myeloid, leukemia, Acute myeloid leukemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Mar 2004
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 20 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Against the background that about 40% of the patients still die from immediate causes of an underlying disease relapse or of nonresponse, it seems to be justifiable to intensify therapy - especially for high-risk patients - which on its parts will require an optimization of supportive measures. As the present risk stratification into standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the risk-adapted therapy strategy.
The aim of the study is to improve prognosis in children with AML by intensification of cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.
Detailed description
During the last decade, prognosis in acute myelogenous leukemia (AML) in childhood has improved considerably, but still 30% of the children experience a relapse of disease and further 10% fail to respond sufficiently to the present therapies. A further intensification of therapy might improve the overall survival of these children, but possible, implicit side effects have to be considered carefully. Increase in dose intensification of the proven, effective anthracyclines will be limited by the risk of cumulative cardiotoxicity. A liposomal formulation of daunorubicin may offer a possibility to increase dosage, at least partially, without causing cumulative cardiotoxicity. Objective one of this randomised study is to ascertain if this dose increase improves therapy response and overall survival at acceptable toxicity. The previous experiences with liposomal daunorubicin, gathered from the relapse studies AML-BFM Rez 97 and International Therapy Study Relapsed AML 2001/012 as well as from the pilot study AML-BFM 2002P, have shown that the induction therapy is feasible in clinical centers with experience in AML therapy without leading to a marked increase of toxicity or prolongation of granulocytopenia.
First results of study AML-BFM 98 have shown that the patients of the standard risk (SR) group did not benefit from an additional, second induction (HAM). On this account we did not reintroduce this second induction course in the present study AML-BFM 2004. However, SR patients will take part in the randomisation of initial therapy with a general view to achieving higher effectiveness.
For patients of the high-risk group, the administration of 2-chloro-2-deoxyadenosine (2-CDA) will be integrated in the first phase of consolidation to achieve an even higher intensification. It could be shown that 2-CDA possesses good antileukemic activity in pediatric and adult AML. In a phase-II study it could also be demonstrated that 2-CDA has good effectiveness in combination with cytarabine. Results of phase-II studies conducted at St. Jude Children's Hospital, Memphis, showed that 2-CDA has good effectiveness especially in children with monoblastic leukemias (FAB M4/M5). Consequently, this intensification for high-risk patients, who present in more than half of the cases with monoblastic leukemias (FAB M4/5), may allow further improvement of therapy for this cohort. The pilot study AML-BFM 2002P confirmed that the study design was practicable without increasing significantly the risk of higher toxicity. However, median duration of aplasia was significantly prolonged in comparison to that of the AI (cytarabine, idarubicin)-block. Objective two of this study is to determine by randomisation if an improvement of efficiency is possible.
Study AML-BFM 98 has already focussed on the question of whether or not doses of CNS irradiation of 12 Gy and 18 Gy are equivalent with regard to their capacity of reducing the risk of relapse. As the results of study AML-BFM 87 confirmed the necessity of CNS irradiation, but did not reveal the necessary minimum dose, this randomisation has been implemented in order to prevent, as far as possible, late sequelae of CNS irradiation by reducing the radiation dose (= objective three).
As the number of patients of study AML-BFM 98 was not sufficient to resolve this question, this randomised analysis has been extended for a second period and will therefore be continued in the current study AML-BFM-2004.
Besides the intensification of cytostatic therapy, study AML-BFM 2004 seeks to optimise the quality of supportive therapy by implementing measures of quality assurance. This demands an up-to-date, complete documentation of each therapy phase. In studies AML-BFM 93 and 98, about 12% of deaths were due to primary complications such as leukostasis syndrome, haemorrhage or severe infections (4%), infections in aplasia before achieving remission (4%) or infections in remission (4%). Maybe the lives of even more children will be saved in the future by improved standards for the prevention of primary complications. Further, the efficacy of chemotherapy could be improved by less delays in therapy which are often due to infections or other complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: liposomal daunorubicinDaunoxome, standard risk |
| 2 | Active comparator | Drug: AnthracyclinesIdarubicin, standard risk |
| 3 | Experimental | Drug: 2-CDADaunoxome, high-risk, 2-CDA |
| 4 | Active comparator | Drug: AIIdarubicin, high-risk, nothing |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age from >0 to </=18 years
- De novo AML, including children with Down syndrome, primary myelosarcomas or acute mixed lineage leukemia/biphenotypic leukemia (predominantly myeloid)
- Admission to one of the member hospitals in Germany participating in the study AML-BFM 2004
Key exclusion criteria (4 listed)
- Children with pre-existing syndromes (except Down syndrome)
- AML as secondary malignancy
- Accompanying diseases which do not allow therapy according to the protocol
- Pre-treatment for more than 14 days with another intensive induction therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnthracyclinesAlso: Idarubicin3x12 mg/qm | Drug | 2 |
| liposomal daunorubicinAlso: Daunoxome3x80 mg/qm | Drug | 1 |
| 2-CDAAlso: Cladribine2x6 mg/qm | Drug | 3 |
| AIAI | Drug | 4 |
Primary outcome
Event-free and absolute survival from the date of diagnosis concerning objective 1 and from the date of randomisation concerning objective 2
Time frame: 5 years
Concerning objective 3: Disease-free survival from the date of randomisation
Time frame: 5 years
1 secondary outcome
Cardiotoxicity
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- Derived from this study: PubMed 40803346Steidel E, Orhan E, Rasche M, Pigazzi M, Tregnago C, Hoffmeister LM, Walter C, Dworzak M, Muhlegger N, von Neuhoff N, Locatelli F, Reinhardt D, Schneider M. Prognostic Value of Molecular Genetic Measurable Residual Disease (MRD) Monitoring in Pediatric Acute Myeloid Leukemia Expressing KMT2A::MLLT10. Eur J Haematol. 2025 Nov;115(5):493-504. doi: 10.1111/ejh.70019. Epub 2025 Aug 13.
- Derived from this study: PubMed 27269945Tramsen L, Salzmann-Manrique E, Bochennek K, Klingebiel T, Reinhardt D, Creutzig U, Sung L, Lehrnbecher T. Lack of Effectiveness of Neutropenic Diet and Social Restrictions as Anti-Infective Measures in Children With Acute Myeloid Leukemia: An Analysis of the AML-BFM 2004 Trial. J Clin Oncol. 2016 Aug 10;34(23):2776-83. doi: 10.1200/JCO.2016.66.7881. Epub 2016 Jun 6.
- Derived from this study: PubMed 26814618Hassler A, Bochennek K, Gilfert J, Perner C, Schoning S, Creutzig U, Reinhardt D, Lehrnbecher T. Infectious Complications in Children With Acute Myeloid Leukemia and Down Syndrome: Analysis of the Prospective Multicenter Trial AML-BFM 2004. Pediatr Blood Cancer. 2016 Jun;63(6):1070-4. doi: 10.1002/pbc.25917. Epub 2016 Jan 27.
- Derived from this study: PubMed 23704089Creutzig U, Zimmermann M, Bourquin JP, Dworzak MN, Fleischhack G, Graf N, Klingebiel T, Kremens B, Lehrnbecher T, von Neuhoff C, Ritter J, Sander A, Schrauder A, von Stackelberg A, Stary J, Reinhardt D. Randomized trial comparing liposomal daunorubicin with idarubicin as induction for pediatric acute myeloid leukemia: results from Study AML-BFM 2004. Blood. 2013 Jul 4;122(1):37-43. doi: 10.1182/blood-2013-02-484097. Epub 2013 May 23.
- Derived from this study: PubMed 21480469Creutzig U, Zimmermann M, Bourquin JP, Dworzak MN, Fleischhack G, von Neuhoff C, Sander A, Schrauder A, von Stackelberg A, Ritter J, Stary J, Reinhardt D. CNS irradiation in pediatric acute myleoid leukemia: equal results by 12 or 18 Gy in studies AML-BFM98 and 2004. Pediatr Blood Cancer. 2011 Dec 1;57(6):986-92. doi: 10.1002/pbc.22955. Epub 2011 Apr 7.
- Derived from this study: PubMed 18182574Klusmann JH, Creutzig U, Zimmermann M, Dworzak M, Jorch N, Langebrake C, Pekrun A, Macakova-Reinhardt K, Reinhardt D. Treatment and prognostic impact of transient leukemia in neonates with Down syndrome. Blood. 2008 Mar 15;111(6):2991-8. doi: 10.1182/blood-2007-10-118810. Epub 2008 Jan 8.
- Derived from this study: PubMed 18083847Meyer LH, Queudeville M, Eckhoff SM, Creutzig U, Reinhardt D, Karawajew L, Ludwig WD, Stahnke K, Debatin KM. Intact apoptosis signaling in myeloid leukemia cells determines treatment outcome in childhood AML. Blood. 2008 Mar 1;111(5):2899-903. doi: 10.1182/blood-2007-08-109058. Epub 2007 Dec 14.
- Click here for more information about this study: Multicenter Therapy-Optimization Trial AML-BFM 2004 for the Treatment of Acute Myeloid Leukemias in Children and AdolescentsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula Creutzig, Prof. Dr. med. principal investigator
Medical School Hannover
Dirk Reinhardt, Prof. Dr. med. principal investigator
Medical School Hanover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anthracyclines, liposomal daunorubicin and 2-CDA in people with Myeloid Leukemia, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free and absolute survival from the date of diagnosis concerning objective 1 and from the date of randomisation concerning objective 2 (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00111345, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.